ABSTRACT

Medicinal products for the diagnosis, prevention or treatment of life-threatening or crippling rare diseases are orphan medicinal products. They are 'orphans' because the pharmaceutical industry has no interest in producing and selling medicines intended for only a limited number of patients suffering from extremely rare conditions under normal market conditions. The law on orphan drugs provides the pharmaceutical industry with a number of incentives and conditions for producing medicines for the treatment of rare diseases. Currently, the number of items for orphans approved (centralized level) is far beyond anything seen before the law on orphan drugs. Furthermore, the final stage relates to whether a patient is able to receive care in a timely and reimbursed manner at the level of the payer (decentralized process), resulting in inconsistency between European countries in patient access. The lack of orphan drug control has a negative effect on the economic development of the Indian medicine industry. The present study analyses and increases the orphan drug laws in the United States, the EU. Any of the current problems relevant to their legislation. Keywords: Medicinal products, Orphans, Life-threatening, Centralized, Decentralized, Legislation
Publication date: 01/12/2021

https://ijbpas.com/pdf/2021/December/MS_IJBPAS_2021_5745.pdf

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https://doi.org/10.31032/IJBPAS/2021/10.12.5745